TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Triamterene (UNII: WS821Z52LQ) (Triamterene - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Commercializzato da:

Preferred Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous

Dettagli prodotto:

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval bioconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied as follows: Dispense with a child-resistant closure in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 75 mg/50 mg Repackaged by Preferred Pharmaceuticals, Inc. Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised September 2011 Rev. 2

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
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TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, 37.5 MG/ 25 MG AND 75
MG/50 MG
DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene, a
potassium-conserving diuretic, with the
natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP
contains 37.5 mg of
Triamterene, USP and 25 mg of Hydrochlorothiazide, USP.
Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP
contains 75 mg of Triamterene,
USP and 50 mg of Hydrochlorothiazide, USP.
Triamterene and hydrochlorothiazide tablets for oral administration
contains the following inactive
ingredients: lactose monohydrate, magnesium stearate, microcrystalline
cellulose, and sodium starch
glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow
No.10 Aluminum Lake and FD&C
Blue No.1 Aluminum Lake.
Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is
practically insoluble in water, benzene,
chloroform, ether and dilute alkali hydroxides. It is soluble in
formic acid and sparingly soluble in
methoxyethanol. Triamterene is very slightly soluble in acetic acid,
alcohol and dilute mineral acids.
The following is the structural formula:
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4,
benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is slightly soluble in water and freely soluble in
sodium hydroxide solution, n-
butylamine and dimethylformamide. It is sparingly soluble in methanol
and insoluble in ether,
chloroform and dilute mineral acids. Its molecular weight is 297.73.
The following is the structural
formula:
CLINICAL PHARMACOLOGY
Triamterene and hydrochlorothiazide is a diuretic, antihypertensive
drug product, principally due to its
hydrochlorothiazide component; the triamterene component reduces the
excessive potassium loss which
may occur with hydrochlorothiazide use.
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide is a diuretic and antihyperten